Quality of Life in Asthmatic Children at School Age
1 other identifier
interventional
40
0 countries
N/A
Brief Summary
Asthma is the most common chronic disease in childhood \[1\]. The advantage of an educational program in a global strategy of care has been established in asthma (decrease of nocturnal asthma, absence from work and school) \[2, 3\]. Therapeutic education of the patient permits the reduction of the rate of hospitalization, of the rate of emergencies visits and non-programmed visits. \[3\]. The WHO defines quality of life as an individual's perception of its place in existence, in the context of culture and value system in which he lives, in relation to its objectives, expectations, standards and concerns \[4\]. The basic point of this concept is the notion of perception, emphasizing the perspective of the person. It is a broad concept affected in a complex way by the subject's physical health, psychological state, level of independence, social relationships, and its relations with its environment. In the field of health, analyzing the quality of life includes objective aspects (living conditions, functional health) and subjective aspects (satisfaction, happiness, well-being) that allow to understand the situation of people in whole. As defined by the WHO-Europe report published in 1996 \[5\], the therapeutic education aims to help patients acquire or maintain the competencies they need to best manage their lives with a chronic disease. It is entirely part of the management of the patient. It includes organized activities designed to make patients aware and informed of their disease, of care organization and hospital procedures, and the behaviors related to health and disease. This is to help them and their families understand their illness and treatment, to work together and to gain autonomy from their disease in order to help maintain and improve their quality of life \[6\]. However, studies demonstrating the effectiveness of therapeutic patient education are still very few, especially in children. The need for prospective studies including the evaluation of the impact on quality of life was highlighted in a recent Cochrane meta-analysis \[7\]. It seems interesting for the authors to assess the improvement of the quality of life after educational sessions in children at school-age.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable asthma
Started Dec 2011
Shorter than P25 for not_applicable asthma
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 23, 2011
CompletedFirst Posted
Study publicly available on registry
November 22, 2011
CompletedStudy Start
First participant enrolled
December 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2012
CompletedNovember 22, 2011
November 1, 2011
4 months
September 23, 2011
November 17, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
AUQUEI questionnaire (Asthma Caregiver's Quality of Life)
3 or 4 months after the diagnosis of asthma
Secondary Outcomes (3)
Clinical control of asthma measured by the Asthma Control Test
3 or 4 months after the diagnosis of asthma
Frequence and severity of the exacerbations
3 or 4 months after the diagnosis of asthma
assessment of pulmonary function by spirometry
3 or 4 months after the diagnosis of asthma
Interventions
Longitudinal prospective study
Eligibility Criteria
You may qualify if:
- School-aged (from 5 to 10 years old) asthmatic children consulting for the first time a paediatric pulmonologist
You may not qualify if:
- Other non-atopic chronic disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
André LABBE, Md, PhD
University Hospital, Clermont-Ferrand
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 23, 2011
First Posted
November 22, 2011
Study Start
December 1, 2011
Primary Completion
April 1, 2012
Study Completion
October 1, 2012
Last Updated
November 22, 2011
Record last verified: 2011-11